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Efficacy of PENNSAID® for Pain Management in the Emergency Department

Primary Purpose

Pain, Ankle Sprain

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PENNSAID
Diclofenac hydroxyethylpyrrolidine
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pain management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion:

-We will include ED patients presenting with an acutely painful ankle sprain for which NSAIDs constitute standard of care pain management.

The following will be excluded:

  • Those with lacerations, bites, burns
  • any head trauma
  • pregnant
  • anyone with a pre-existing chronic pain condition
  • inflammatory intestinal disorders such as Crohn's disease or ulcerative colitis
  • anyone regularly using another NSAID or anti-coagulation medication
  • anyone who has experienced asthma after NSAID use
  • compromised cognitive abilities
  • a significant co-morbidity that will compromise participation
  • had joint replacements
  • known hypersensitivity to diclofenac or allergic responses to NSAIDs as a class
  • active stomach and/or duodenal ulceration or gastrointestinal bleeding
  • anyone admitted with severe active bleeding
  • recent heart surgery
  • severe liver or renal insufficiency
  • prisoner
  • mentally disabled patients
  • wards of the state
  • cognitive or decisional impairment

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pennsaid

Oral Diclofenac

Arm Description

Active Pennsaid and oral placebo

Oral diclofenac and placebo lotion (2.3% DMSO solution)

Outcomes

Primary Outcome Measures

Change in pain score
Compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac.

Secondary Outcome Measures

pain trajectory model
The secondary goal of the proposed work is to discover and model the onset and course of pain relief during the ED visit

Full Information

First Posted
April 29, 2011
Last Updated
December 19, 2016
Sponsor
University of Utah
Collaborators
Medtronic - MITG
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1. Study Identification

Unique Protocol Identification Number
NCT01350622
Brief Title
Efficacy of PENNSAID® for Pain Management in the Emergency Department
Official Title
Efficacy of PENNSAID® for Pain Management in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Study never initiated
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
Collaborators
Medtronic - MITG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac under double blind conditions using a growth curve approach to pain measurement. The investigators will test the hypothesis that PENNSAID will provide more rapid pain relief than oral diclofenac during the ED visit. The secondary goal of the proposed work is to discover and model the onset and course of pain relief during the emergency department (ED) visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Ankle Sprain
Keywords
pain management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pennsaid
Arm Type
Experimental
Arm Description
Active Pennsaid and oral placebo
Arm Title
Oral Diclofenac
Arm Type
Active Comparator
Arm Description
Oral diclofenac and placebo lotion (2.3% DMSO solution)
Intervention Type
Drug
Intervention Name(s)
PENNSAID
Intervention Description
active treatment with PENNSAID and oral placebo. Subjects will apply 40 drops of Pennsaid to the affected ankle joint once, and will take a single placebo pill.
Intervention Type
Drug
Intervention Name(s)
Diclofenac hydroxyethylpyrrolidine
Intervention Description
active treatment oral Diclofenac and PENNSAID placebo. Patients will take a single 50mg dose of oral diclofenac and will apply 40 drops of placebo lotion (2.3% DMSO) to the affected ankle once.
Primary Outcome Measure Information:
Title
Change in pain score
Description
Compare the pain relieving effect and speed of onset of PENNSAID to that of standard oral diclofenac.
Time Frame
Measure at 5 minute intervals for the duration of the ER visit
Secondary Outcome Measure Information:
Title
pain trajectory model
Description
The secondary goal of the proposed work is to discover and model the onset and course of pain relief during the ED visit
Time Frame
nine months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion: -We will include ED patients presenting with an acutely painful ankle sprain for which NSAIDs constitute standard of care pain management. The following will be excluded: Those with lacerations, bites, burns any head trauma pregnant anyone with a pre-existing chronic pain condition inflammatory intestinal disorders such as Crohn's disease or ulcerative colitis anyone regularly using another NSAID or anti-coagulation medication anyone who has experienced asthma after NSAID use compromised cognitive abilities a significant co-morbidity that will compromise participation had joint replacements known hypersensitivity to diclofenac or allergic responses to NSAIDs as a class active stomach and/or duodenal ulceration or gastrointestinal bleeding anyone admitted with severe active bleeding recent heart surgery severe liver or renal insufficiency prisoner mentally disabled patients wards of the state cognitive or decisional impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Chapman, PhD
Organizational Affiliation
University of Utah
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Virgil Davis, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16086839
Citation
Baer PA, Thomas LM, Shainhouse Z. Treatment of osteoarthritis of the knee with a topical diclofenac solution: a randomised controlled, 6-week trial [ISRCTN53366886]. BMC Musculoskelet Disord. 2005 Aug 8;6:44. doi: 10.1186/1471-2474-6-44.
Results Reference
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PubMed Identifier
21237721
Citation
Chapman CR, Donaldson GW, Davis JJ, Bradshaw DH. Improving individual measurement of postoperative pain: the pain trajectory. J Pain. 2011 Feb;12(2):257-62. doi: 10.1016/j.jpain.2010.08.005. Epub 2011 Jan 15.
Results Reference
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PubMed Identifier
19943711
Citation
Moen MD. Topical diclofenac solution. Drugs. 2009;69(18):2621-32. doi: 10.2165/11202850-000000000-00000.
Results Reference
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PubMed Identifier
18570
Citation
Pritchard PH, Brindley DN. Studies on the ethanol-induced changes in glycerolipid synthesis in rats and their partial reversal by N-(2-benzoyloxyethyl)norfenfluramine (benfluorex). J Pharm Pharmacol. 1977 Jun;29(6):343-9. doi: 10.1111/j.2042-7158.1977.tb11332.x. No abstract available.
Results Reference
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PubMed Identifier
20854305
Citation
Galer BS. A comparative subjective assessment study of PENNSAID(R) and Voltaren Gel(R), two topical formulations of diclofenac sodium. Pain Pract. 2011 May-Jun;11(3):252-60. doi: 10.1111/j.1533-2500.2010.00420.x. Epub 2010 Sep 20.
Results Reference
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PubMed Identifier
15477437
Citation
Roth SH, Shainhouse JZ. Efficacy and safety of a topical diclofenac solution (pennsaid) in the treatment of primary osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled clinical trial. Arch Intern Med. 2004 Oct 11;164(18):2017-23. doi: 10.1001/archinte.164.18.2017.
Results Reference
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PubMed Identifier
15039693
Citation
Rupp T, Delaney KA. Inadequate analgesia in emergency medicine. Ann Emerg Med. 2004 Apr;43(4):494-503. doi: 10.1016/j.annemergmed.2003.11.019.
Results Reference
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PubMed Identifier
17306626
Citation
Todd KH, Ducharme J, Choiniere M, Crandall CS, Fosnocht DE, Homel P, Tanabe P; PEMI Study Group. Pain in the emergency department: results of the pain and emergency medicine initiative (PEMI) multicenter study. J Pain. 2007 Jun;8(6):460-6. doi: 10.1016/j.jpain.2006.12.005. Epub 2007 Feb 15.
Results Reference
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PubMed Identifier
16511925
Citation
Towheed TE. Pennsaid therapy for osteoarthritis of the knee: a systematic review and metaanalysis of randomized controlled trials. J Rheumatol. 2006 Mar;33(3):567-73.
Results Reference
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PubMed Identifier
15468367
Citation
Tugwell PS, Wells GA, Shainhouse JZ. Equivalence study of a topical diclofenac solution (pennsaid) compared with oral diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial. J Rheumatol. 2004 Oct;31(10):2002-12.
Results Reference
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PubMed Identifier
9794502
Citation
Hui X, Hewitt PG, Poblete N, Maibach HI, Shainhouse JZ, Wester RC. In vivo bioavailability and metabolism of topical diclofenac lotion in human volunteers. Pharm Res. 1998 Oct;15(10):1589-95. doi: 10.1023/a:1011911302005.
Results Reference
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Efficacy of PENNSAID® for Pain Management in the Emergency Department

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